Course catalogue doctoral education - HT21

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Title Clinical Trials in Cardiovascular Research
Course number 3173
Programme Kardiovaskulär forskning
Language English
Credits 1.5
Date 2021-12-16 -- 2021-12-22
Responsible KI department Institutionen för medicin, Solna
Specific entry requirements
Purpose of the course Purposes of the course are to:
- Improve knowledge and skills related to clinical trial planning and design as well as successful running of different types of clinical trials (observational studies, registries, randomized trials);
- Provide an overview of some recent key trials in the cardiovascular arena.
Intended learning outcomes After the course, the participants should be able to:
- know how to design, plan and run a successful clinical trial
- account for the relevant regulatory aspects involved in the process of designing and running a clinical trial
- analyze and interpret trial data
- critically review literature of clinical trials
- predict important statistical issues (e.g. different types of adjustments for confounders, biases, how to perform subgroup analysis in trials, statistical methods for meta-analyses) related to different trial designs (e.g. observational studies, registries, randomized trials and meta-analyses).
Contents of the course Lectures/Seminars/Workshops on the following topics:
- Different designs of clinical trials
- Requirements from regulatory agencies and post marketing surveillance
- Upcoming and ongoing cardiovascular clinical trials (e.g. antithrombotics, lipidology, diabetes, heart failure)
- Implementation of GCP and ethical principles in clinical trials
- Statistical issues in clinical trials
- How to interpret clinical trials
Teaching and learning activities - Lectures/workshops, debates on important clinical trials (2 days)
- Home-based studying and preparation of the exam - group work (2 days)
- Presentation and discussion of your own design of a clinical trial (1 day)
Compulsory elements Participants should attend all the sessions except the GCP training (which is not mandatory and will be performed only if the course won´t be virtual) and be involved in group work and presentation of the home assignment. The students who have missed course sessions will be assigned extra reading and home work to compensate the absence.
Examination Home-based group assignment (design of a clinical trial on a topic of students' choice) which will be presented/discussed on the examination date. Each individual will be assessed on the basis of the achievement of the intended learning outcomes of the course.
Literature and other teaching material Recommended reading materials will be provided well in advance of the course.
Number of students 8 - 50
Selection of students Selection will be based on: 1) the relevance of the course syllabus for the applicant's doctoral project (according to written motivation), 2) start date of doctoral studies (priority given to earlier start date)
More information December 16th and 17th 2021: frontal teaching/workshops. December 20th and 21st 2021: home study and preparation of the exam in groups of 4/5 students (home-based). December 22th 2021: exam. Location: Karolinska University Hospital/Karolinska Institutet, Solna or Zoom/other virtual platform depending on the regulations for Covid-19 in December. The course is run in collaboration with the European Society of Cardiology - Working Group on Cardiovascular Pharmacotherapy, which will provide well-known global trialists as speakers. National experts on cardiovascular clinical trials will also be part of the team of teachers.
Additional course leader
Latest course evaluation Course evaluation report
Course responsible Gianluigi Savarese
Institutionen för medicin, Solna

gianluigi.savarese@ki.se
Contact person -